Duns Number:092815364
Device Description: FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RS FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
Catalog Number
751110
Brand Name
FLU/RSV Positive Control
Version/Model Number
751110
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 13, 2021
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071101
Product Code
GQG
Product Code Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Public Device Record Key
db9fefcd-9c8a-4a2d-9bc9-a746f737af0d
Public Version Date
June 21, 2021
Public Version Number
2
DI Record Publish Date
November 17, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |